Kornimate/medical-research-clean huggingface dataset:
evaluation of the effect of mediterranean diet on breast cancer patients

Conditions: Breast Cancer

Summary: in this study, it was aimed to evaluate the effect of the mediterranean diet on body composition, oxidant stress and proinflammatory markers in overweight and obese breast cancer women.

breast cancer is the most common type of cancer among women in both developed and developing countries and is the leading cause of cancer death among women worldwide. breast cancer is a disease that can develop and progress for various reasons. in addition to unchangeable factors such as increasing age and genotype, modifiable factors such as smoking, alcohol consumption, lack of physical activity, malnutrition, and obesity play a role in the pathogenesis of the disease. breast cancer risk increases with increasing body mass index (bmi) in postmenopausal women. chronic inflammation in obesity is associated with an increase in the release of proinflammatory factors (such as tnf-α, il-1, il-6). this situation; it is a risk factor for many types of cancer such as colon, stomach, breast and prostate carcinomas and supports a cause-effect relationship between obesity and cancer. these proinflammatory factors act as signal converters for tumor growth and progression. obese women have elevated levels of tnf-α and il-6 in the circulation, and this is associated with the development and progression of breast tumors. the mediterranean diet, which consists of high amounts of monounsaturated fatty acids, fruits, vegetables and whole grains, has been widely evaluated and indicated as an important factor in preventing tumor formation from inflammatory pathways. weight loss improves the antitumor immune system, lowers estrogen levels, reduces the risk of breast cancer and has been associated with better outcomes in obese patients. lifestyle intervention studies strongly suggest that weight loss is possible and observational studies can actually improve breast cancer survival.in this regard, a healthy lifestyle and diet are the first steps to prevent breast cancer.

Eligibility criteria:
inclusion criteria: * at least 18 years old, * bmi value to be ≥25 kg/m2, * to be diagnosed with breast cancer stage i, ii or iii, * being a positive hormone receptor status, one of the biological subtypes of breast cancer, * having completed chemotherapy and / or radiotherapy treatment at least 6 months before starting the study, * not applying any treatment for body weight loss, * accepting to participate in the study, * perceiving disorder and not having communication problems. exclusion criteria: * being under the age of 18 and over the age of 65, * bmi value to be 40 kg/m2, * having advanced stage breast cancer (iv and v), * being diagnosed with cancer or metastasis in other organs, * being one of the biological subtypes of breast cancer, hormone receptor status being negative, * using antioxidant vitamin-mineral supplements, * using herbal supplements, * being pregnant or planning a pregnancy, * to stop working after starting diet therapy.

Keywords: diet therapy mediterranean diet oxidant stress markers proinflammatory markers body composition
treatment of gambling disorder with fast acting opiate antagonist, naloxone nasal spray

Conditions: Gambling; Opioid; Naloxone; Spray

Summary: non-controlled pilot study. two groups: group a: naloxone nasal spray max 8 mg/per day; group b: naloxone max 16 mg/per day. study duration 8 weeks. brief intervention.

non-controlled pilot study. two groups: group a: naloxone nasal spray max 8 mg/per day; group b: naloxone max 16 mg/per day. study duration 8 weeks. no supportive therapy, but brief self-help booklet. primary outcomes: adverse events, adherence and drop out analysis. secondary outcome: gambling expenditure.

Eligibility criteria:
inclusion criteria: * age over 18 years old * south oaks gambling scale (sogs) 5 or over points * possibility to keep a record with phone and send text messages * fluent in finnish language exclusion criteria: * active drug use (specially opioids) current use - drugs screen * nasal abnormality or mucosal irritability * hepatitis c virus, kidney insufficiency * psychosis, unstable mental health, risk suicide (beck depression inventory) * pregnancy and/or breast feeding * persons according to finnish medical law 188/1999 §7-10

Keywords: antagonist nasal
cardiovascular safety study of magnevist® injection at two dose levels and two injection rates in normal subjects

Conditions: Healthy

Summary: the purpose of this study is to determine what effect magnevist (gadopentetate dimeglumine) injection has on the way the heart conducts the electrical impulses that allow it to beat effectively. the study will compare magnevist injection's effect to that of placebo (a saline injection).

this study has previously been posted by berlex, inc. berlex, inc. has been renamed to bayer healthcare pharmaceuticals, inc.bayer healthcare pharmaceuticals, inc.is the sponsor of the trial.

Eligibility criteria:
inclusion criteria: * subjects with an electrocardiogram \[ecg\] (normal sinus rhythm \[sr\], qtc \> 450 msec) without clinically significant abnormalities * non-smoker exclusion criteria: * history of cardiovascular disease- pregnant or nursing- had any contraindication to moxifloxacin

Keywords: ecg safety
the tolerability and pharmacokinetics study of hec74647pa capsule in healthy adult subjects

Conditions: Chronic Hepatitis c

Summary: the tolerability and pharmacokinetics study of hec74647pa capsule in healthy adult subjects

a phase i, single center, randomized, double-blind, placebo-controlled, single \& multiple ascending dose study to access the tolerability and pharmacokinetics of hec74647pa capsule in healthy adult subjects.

Eligibility criteria:
inclusion criteria: * able to comprehend and sign the icf voluntarily prior to initiate the study; * able to complete the study according to the protocol; * between 18 and 45 years of age, inclusive, male subject should be no fertility needs; * body weight of male and female subject should be ≥50 kg and ≥45 kg respectively; body mass index (bmi) is between 18 and 28 kg/m2, inclusive; * physical examination and vital signs without clinically significant abnormalities. exclusion criteria: * smokers, who smoke more than 5 cigarettes/day within 3 months before the study; * drink frequently, namely alcohol consumption are 14 units per week (1 unit = 285 ml of beer, or 25 ml of strong wine, or 100 ml of grape wine); * donated blood or massive blood loss within 3 months before screening (\>450 ml）; * have any disease that increases the risk of bleeding, such as acne, acute gastritis or stomach and duodenal ulcers; * have taken any prescription drug, over-the-counter drug, vitamin product or herbal medicine within 1 month prior to screening; * have participated in any clinical trial or taken any study drug within 3 months before dosing; * viral hepatitis（including chb and chc）and positive test result of anti-hiv ab or syphilis.
the heart hive - cardiomyopathy study

Conditions: Cardiomyopathies; Myocarditis

Summary: this is an online registry and database of patients with cardiomyopathy and myocarditis, coupled with an observational study of dcm and hcm.

this study utilises the heart hive, an international, online registry of patients with self-reported clinically diagnosed cardiomyopathy or myocarditis, and people with a family history of cardiomyopathy, enrolled on an on-going basis. registry participants are invited to enter self-reported demographics and health data relevant to their cardiac diagnosis into the heart hive online database. registry participants with self-reported clinically diagnosed dilated (dcm )or hypertrophic (hcm) cardiomyopathy will be recruited to an observational, prospective study entailing collection of patient-reported baseline demographic data and clinical risk factors, genotyping, and annual collection of follow up data from patients, national registries (nhs digital) and medical records. in the pilot phase 100 dcm and 100 hcm patients will be recruited to a validation study. consent will be sought to access medical information from health care providers in order to compare against and confirm self-reported health information. dna will be obtained from saliva samples and tested in-house using a panel of clinically validated known mendelian dcm and hcm genes as a second validation of the accuracy of self-reported diagnosis and to confirm equivalent genetic architecture of dcm and hcm in direct-to-patient recruited cohorts compared to traditional centre of excellence clinic-based recruitments. following validation of the approach and once funding is in place for genomic studies, larger numbers of affected dcm and hcm patients will be recruited to this study from the registry of research willing participants.

Eligibility criteria:
inclusion criteria: * adult (age 18 and over), * males and females, * capacity to provide informed consent, * patients with a confirmed diagnosis of cardiomyopathy or myocarditis, * people with a family history of cardiomyopathy confirmed in a first or second degree relative. note: pregnant women are eligible. this study is observational and entirely separate from clinical care. exclusion criteria: * patients who lack capacity to consent for themselves, * vulnerable groups (e.g. those under 18, prisoners, those in a dependent relationship, the mentally ill). * patients with a confirmed history of coronary artery disease: * who have been informed by their treating physician that their cardiomyopathy is secondary to their coronary artery disease, or * who have undergone previous percutaneous coronary intervention or coronary bypass surgery * history of primary valvular heart disease or congenital heart disease * severe, untreated or untreatable hypertension (systolic blood pressures routinely \>180 mm hg and/or diastolic blood pressures \>120 mm hg)
permeaderm versus homograft for full-thickness burns

Conditions: Full Thickness Burn

Summary: frozen human cadaver allograft (fhca) is, nowadays, the gold standard for temporary coverage of excised full-thickness burns, but is also very expensive and requires additional personnel and major storage spaces in comparison to other products. the purpose of this study is to determine the extent to which permeaderm® dressing promotes wound bed maturation when used as a temporary dressing for excised full-thickness burn wounds. efficacy and safety in promoting wound bed maturation for successive autografting will be determined through direct comparison to fhca.

in this prospective, randomized, matched design pilot study, we aim to compare the current standard of care fhca to permeaderm®. 30 patients for each study arm (n total = 60) meeting the inclusion criteria will be enrolled to randomly receive fhca and permeaderm® on two adjacent or symmetric body areas. prior to randomization of study areas and application of study dressings, baseline assessments of wound size and burn depth will be performed by the experienced physician and documented using photography and when indicated laser doppler (moor laser speckle®, moor instruments, devon, uk) measurements. percentage of graft take and wound healing after removal of the temporary wound dressings and secondary autografting (study arm 1) or after excision and direct autografting with wiedely-meshed autograft and temporary wound dressings as overlay (study arm 2) will be assessed. secondary outcomes will include complications such as infections, signs of rejection/non-adherence, fluid accumulation/hematoma beneath dressings and mid- and long-term clinical scar maturation, as assessed by the posas and objectively with the dermalab combo® device (cortex technology aps, hadsund, denmark).

Eligibility criteria:
inclusion criteria: * ≥ 2 % total body surface area (tbsa) full thickness burned. * patients with two adjacent or body symmetrical full thickness burned areas (each ≥ 1 tbsa) and comparable in size (tbsa ± 0.5), that require debridement and autografting. exclusion criteria: * time from injury to admission \>= 5 days * sepsis on admission or clinically suspected infection (as per attending physician) * pregnancy or childbearing * positive hiv or hepatitis screens * history of active malignancy * patients who do not require surgical debridement and autografting * patient with burn injuries originating from other causes (chemical, and frostbite)

Keywords: permeaderm cadaver skin full thickness burn temporary coverage
efficacy of wharton jelly in erectile dysfunction

Conditions: Erectile Dysfunction Associated With Type 2 Diabetes Mellitus

Summary: efficacy of intracavernous injection of wharton jelly mesenchymal stem cells for the treatment of erectile dysfunction in diabetic patients.

this study will be conducted at the cell therapy center (ctc), jordan, in which 22 male patients ranging from 25-70 years diagnosed with erectile dysfunction will be selected. this diagnosis is based on medical history, validated questionnaires, physical examinations, laboratory tests and specific diagnostic tests. the patients are followed by clinical assessment, laboratory investigations as well as doppler ultrasound. the investigators hypothesize that the intracavernous injection of stem cells will facilitate the recovery of erectile function resulting in satisfying clinical outcomes in patients.

Eligibility criteria:
inclusion criteria: 1. adult male patients ranging from 25 to 70 years. 2. history of chronic erectile dysfunction for at least six months. 3. baseline international index of erectile function (iief) score of \< 26. 4. not interested or able to use phosphodiesterase type 5 inhibitor (pd5i) drug therapy and willing to forgo theses treatments for the first 6 month period following study treatment. 5. body mass index between 20-30. 6. willing to provide written informed consent, complete questionnaire, and to be available for all baseline treatment and follow up examinations required by protocol. exclusion criteria: 1. current urinary tract or bladder infection. 2. clinical/laboratory evidence of transmissible diseases. 3. clinically evident penile anatomical deformities(e.g., peyronie's disease) or history of priapism. 4. skin irritation, infection, wound, sore or disruption in the immediate areas of skin entry for penile injection. 5. current or previous malignancy. 6. use of any non study treatment for erectile function within 4 weeks of study treatment. 7. lack of willingness to continue through 6 months after study treatment. 8. any previous penile implant or penile vascular surgery. 9. uncontrolled hypertension or hypotension(systolic blood pressure \> 170 or \ 100 or \< 50 mm hg). 10. reported unstable cardiovascular disease (e.g., unstable angina, myocardial infarction within past 6 months, cardiac failure or life-threatening arrhythmia, congestive heart failure) or symptomatic postural hypotension within 6 months before screening. 11. bleeding or clotting disorder, use of anticoagulant therapy. 12. lab values for complete blood count (cbc), prothrombin time (pt)/ partial thromboplastin time (ptt)/ international normalized ratio (inr), alanine aminotransferase (alt), aspartate aminotransferase (ast) and creatinine falling outside the normal lab values. 13. systemic autoimmune disorder. 14. significant active systemic or localized infection. 15. receiving immunosuppressant medications. 16. post-radical prostatectomy.

Keywords: diabetes wharton jelly mesenchymal stem cells efficacy
a phase 3 study to evaluate the safety of sotagliflozin in patients with type 1 diabetes who have inadequate glycemic control with insulin therapy alone

Conditions: Type 1 Diabetes Mellitus (T1DM); High Level of Sugar (Glucose) in the Blood

Summary: this phase 3 study was designed to demonstrate the net benefit of sotagliflozin versus placebo in patients with type 1 diabetes (t1d).


Eligibility criteria:
inclusion criteria: * participants had given written informed consent to participate in the study in accordance with local regulations * adult participants 18 years and older with a diagnosis of t1dm made at least 1 year prior to informed consent * participants were being treated with insulin or insulin analog * willing and able to perform self-monitoring of blood glucose (smbg) and complete the study diary as required per protocol * at the screening visit, a1c was between 7.0% to 11.0% * females of childbearing potential used an adequate method of contraception and had a negative pregnancy test exclusion criteria: * use of antidiabetic agent other than insulin or insulin analog at the time of screening * use of sodium-glucose cotransporter (sglt) inhibitors within 8 weeks prior to screening * chronic systemic corticosteroid use * type 2 diabetes mellitus (t2dm), or severely uncontrolled t1d as determined by the investigator
quantitative and clinical assessment of flexor tendon gliding following application of a bioresorbable hydrogel: a prospective, randomized study in patients undergoing distal radius fracture repair

Conditions: Distal Radius Fracture; Tendon Rupture

Summary: the investigators will be evaluating the use of versawrap in the setting of distal radius fractures by placing membrane between plate and flexor tendons. investigators will then evaluate tendon gliding morphology and number of tendon ruptures


Eligibility criteria:
inclusion criteria: * cognitively able to converse in english or in native language supported by a certified medical interpreter; * diagnosed with a closed, distal radius fracture treated with open reduction and internal fixation using a volar distal radius plating system. exclusion criteria: * open injury; * concomitant injury to the contralateral wrist; * history of flexor tendon repair involving one or both hands or wrists; * use of a trans-carpal fixation device (bridge plate or external fixator) that would preclude wrist motion post-operatively; * concomitant fracture / injury to the thumb or index finger of one or both hands; * concomitant carpal tunnel release.
a trial of the safety and efficacy of single-dose administration of anb-010 in subjects with hemophilia a

Conditions: Hemophilia A

Summary: the goal of this multicenter, two-stage, open-label study is to investigate the safety, immunogenicity, and efficacy of anb-010 in subjects with hemophilia a. the study will have a dose-escalation design with elements of phase i/ii seamless adaptive design.

the study will be conducted in 2 stages: stage 1: pilot efficacy and safety study of different doses to select a potentially therapeutic dose for further study. stage 2: study of the efficacy and safety of anb-010 at the selected potentially therapeutic dose. the stage 1 design is typical of phase i clinical trials with a modified "3+3" design and dose escalation. three subjects are to be sequentially included in each cohort, each of whom will recieved a pre-specified cohort dose of anb-010 as a single inravenous infusion. subjects will be monitored for dose-limiting toxicity (dlt) events for 4 weeks after the drug infusion. the decision concerning dose escalation will be made at the independent data monitoring committee (idmc) meetings. at the second stage the main study period will include 6 subjects who will receive anb-010 at the optimal dose selected based on the results of stage 1 data analysis.

Eligibility criteria:
inclusion criteria: 1. male subjects aged ≥18 years at the time of signing the informed consent form. 3. established diagnosis of hemophilia a with a documented history of endogenous fviii activity ≤1% and ≤2% at screening. 4. therapy with fviii concentrates for at least 150 exposure days. exclusion criteria: 1. history of use of any gene therapy product. 2. use of emicizumab within less than 6 months before the date of signing the icf. 3. the presence of other blood or hematopoietic disorders other than hemophilia a. 4. presence of aav6 antibodies detected by elisa. 5. bmi \<16 kg/m² or ≥35 kg/m². 6. diagnosis of hiv infection. 7. hbv infection. 8. hcv infection. 9. any active systemic infections or recurrent infections requiring systemic therapy at screening. 10. any other disorders associated with severe immunodeficiency. 11. relevant hepatic disorders or conditions that can be a symptom of existing liver disorder. 12. malignancies with remission duration of less than 5 years at the time of signing the icf, except for cured basal cell carcinoma.
his bundle recording from subclavian vein

Conditions: Atrial Fibrillation; Congestive Heart Failure

Summary: his bundle pacing has been proposed as a superior alternative to standard right ventricular pacing. the purpose of this study is to investigate whether obtaining a his bundle recording from the subclavian vein using a stylet driven pacemaker lead and commercially available sheath can be done in a quick and reliable manner. this would support the use of stylet driven leads for his bundle pacing.

the purpose of this prospective observational study is to investigate whether obtaining a his bundle recording from the subclavian vein using a stylet driven pacemaker lead and commercially available sheath can be done in a quick and reliable manner. included in the study are patients undergoing permanent pacemaker implantation at good samaritan and bethesda north hospitals. the main outcome is successful recording of a his bundle potential. secondary outcomes are the time necessary to record the his bundle and the measurement of the pacing threshold.

Eligibility criteria:
inclusion criteria: age ≥ 18 years male or female patients undergoing his bundle recording from the subclavian vein using a stylet driven pacemaker lead and commercially available sheath exclusion criteria: patients who are unwilling or unable to sign the informed consent pregnant women
korean red ginseng in treating patients with fatigue caused by chemotherapy for colorectal cancer

Conditions: Colorectal Cancer

Summary: korean red ginseng may improve fatigue in healthy subject. it is not yet known whether korean red ginseng is effective compared with a placebo in chemotherapy. the purpose of this study is to determine whether korean red ginseng is effective in the treatment of the fatigue from colorectal cancer with chemotherapy.(modified folfox-6)


Eligibility criteria:
inclusion criteria: * 20 years and older * person who agreed to participate in this study and signed voluntarily on the written informed consent form * person who is confirmed as colorectal cancer through histological and image diagnosis and scheduled for adjuvant or palliative therapy with mfolfox-6 regimen * fertile patients with negative pregnancy test confirmed and who has agreed to use effective contraception * person who is able to fully communicate with the physician about his/her fatigue status and is able to completely fill out the questionnaires * life expectancy more than 6 months * performance status of ecog grade 0\~1 * hb ≥ 9g/dl * person with moderate liver function (ast, alt ≤ 2.5 × uln) * person with moderate renal function (cr ≤ 1.5 × uln) exclusion criteria: * pregnant or nursing women * primary brain cancer, brain metastases or other cns malignancy, including cns lymphoma * no controlled pain despite the use if analgesics. * person showing hypothyroidism despite the hormone treatment * person with insomnia despite an appropriate treatment * no controlled hypertension (dbp \>100mmhg or sbp \>160mmhg) * person who has experience of hypersensitivity to the trial drug (ginseng) components * person with autoimmune disorders (multiple sclerosis, lupus, rheumarthritis etc.) * person who is alcoholic dependent or has psychiatric disorder * person who has cognitive or psychiatric problems * person who has an experience of chemotherapy agents use 6 months before a screening visit * person who had a surgery 2 weeks before a screening visit * person who had taken herbal medicinal product (including chinese medicine) 4 weeks before the screening visit * person who has medical status that is judged to affect the result or who is judged as inappropriate for the study by the physician

Keywords: cancer cancer related fatigue korean red ginseng chemotherapy